BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 4902513 · Received July 9, 2015

    Report

    Report Number
    2029046-2015-00185
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    April 30, 2013
    Report Date
    June 19, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED] BY THE CUSTOMER. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. CONCOMITANT PRODUCTS WERE USED DURING THIS STUDY: CARTO MAPPING SYSTEM OTHER COMPANY¿S DEVICES WERE USED DURING THIS STUDY: STEERABLE SHEATH (AGILIS, ST JUDE MEDICAL), BRK NEEDLE (MEDTRONIC INC), ENSITE NAVX (ST JUDE MEDICAL). CONTACT OFFICE AND MANUFACTURING SITE SHOULD REFLECT: (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4) ARE RELATED TO THE SAME ARTICLE. MANUFACTURER'S REF. NO: (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED THAT ONE PATIENT HAD TRANSIENT ISCHEMIC ATTACK WITHOUT SEQUELAE AFTER VENTRICULAR TACHYCARDIA ABLATION. BASED ON THE FACTS OF THE CASE AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE BWI CATHETERS AND SYSTEMS USED DURING THE CASE. THUS, THIS EVENT IS UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: ¿SCAR DECHANNELING NEW METHOD FOR SCAR-RELATED LEFT VENTRICULAR TACHYCARDIA SUBSTRATE ABLATION.¿ THE PURPOSE OF THIS STUDY WAS TO REPORT THE DETAILS AND OUTCOMES OF THE PROCEDURES WITH SCAR DECHANNELING AS THE FIRST STEP FOR PATIENTS WITH LEFT VENTRICLE SCAR-RELATED VENTRICLE TACHYCARDIA. THE STUDY WAS CONDUCTED BETWEEN NOVEMBER 2009 AND APRIL 2013. OTHER SERIOUS AND NON-SERIOUS ADVERSE EVENTS WERE REPORTED IN THIS ARTICLE (SERIOUS EVENTS ARE REPORTED TO FDA SEPARATELY): - 2 PATIENTS CARDIAC TAMPONADE DURING ENDOCARDIAL ABLATION; - 1 PATIENT POSTPROCEDURAL PERICARDITIS WITH PERICARDIAL EFFUSION REQUIRING PERICARDIOCENTESIS AFTER EPICARDIAL ABLATION; - 1 PATIENT POSTPROCEDURAL PERICARDITIS WITH PERICARDIAL EFFUSION AFTER EPICARDIAL ABLATION; - 1 PATIENT WITH PREVIOUS LEFT BUNDLE BRANCH BLOCK PRESENTED COMPLETE ATRIOVENTRICULAR BLOCK AND UNDERWENT CRT-D IMPLANTATION (CARDIAC RESYNCHRONIZATION THERAPY); - 1 PATIENT WITH PERMANENT ATRIAL FIBRILLATION AND A PREVIOUSLY IMPLANTED SINGLE-CHAMBER ICD (IMPLANTABLE CARDIOVERTER DEFIBRILLATOR), PRESENTED WITH COMPLETE ATRIOVENTRICULAR BLOCK; - 1 PATIENT SYMPTOMATIC PHRENIC NERVE PALSY; - 1 PATIENT WITH NONISCHEMIC CARDIOMYOPATHY HAD CARDIOGENIC SHOCK; SUSPECTED DEVICE IS NAVISTAR THERMOCOOL CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447505 NAVISTAR® THERMOCOOL® SIMILAR DEVICE NI75TCJH, PMA # P030031 LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1197-00 UNKNOWN_NAVISTAR THERMO TC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other